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Treatment Selection by 3D Bioprinting Liver Model to Prevent Liver Cancer Recurrence

Recruitingn/aAges 18 Years - anyAllThe University of Hong Kong
NCT07839767 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study is a feasibility study about a test on adjuvant therapy for patients in hepatocellular carcinoma (HCC) with a higher risk of tumour recurrence after liver resection or ablation. By collecting individual patient's liver and tumour tissue during surgical operation, 3D bioprinting technology will be adopted to construct patient-specific biomimetic liver models -'Liver-in-Cube', to test and identify the most effective adjuvant therapy for individual patients, thereby personalising treatment and improving treatment outcomes, and hence reducing the recurrence rate of HCC. This is a phase II, non-randomised, open-label, single-centre, prospective feasibility study designed to evaluate the use of biomimetic 3D bioprinting technology in guiding the selection of adjuvant treatment regimens to prevent hepatocellular carcinoma (HCC) recurrence after curative liver resection. The study wi

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥ 18 years at the time of screening * Diagnosis of HCC * Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1 * With or without prior locoregional therapy such as transarterial chemoembolisation (TACE), radiofrequency ablation (RFA), and stereotactic body radiation therapy (SBRT) before surgery - Meet any item indicating higher risk of tumour recurrence: any tumour size ≥ 5cm, number of tumour ≥ 3, presence of microvascular or marcovascular invasion, or poor tumour differentiation * No prior systemic therapy for HCC * No other active malignancies within 5 years, except malignancies with a negligible risk of metastasis or death (eg. 5-year overall survival rate \> 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localised prostate cancer, ductal carcinoma in situ, or stage I uterine cancer * Willing and able to provide written informed consent for the collection and usage of biological samples Exclusion Criteria: * Non-HCC diagnosis, including fibrolamellar HCC, sarcomatoid HCC, mixed HCC cholangiocarcinoma etc. * Fail to give consent or refusal to take part in the study * Child-Pugh class C liver cirrhosis * Receipt of any prior systemic therapy for HCC
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What it tests

  • Liver-in-cube testing
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Where

1 site
Queen Mary Hospital
Hong Kong, Hong Kong
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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